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PostmenopausalPhase 2NCT00420576

Dose Finding Study of Danggui Buxue Tang (Herbal Formula)on the Treatment of Menopausal Symptoms

A Phase 2 study testing DBT-Danggui Buxue Tang in people with Postmenopausal, run by Chinese University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Main purpose of the study is to look for an optimal dose for the treatment of menopausal symptoms with the Chinese Herbal Medicines containing Dang Gui and Huang Qi. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postmenopausal
What is being tested?
DBT-Danggui Buxue Tang
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Jun 2006to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Follicle stimulating hormone (FSH), luteinizing hormone (LH), oestradiol in the menopausal range (FSH>18 IU/L, LH>12.6 IU/L, and E2< 361 pmol/l)
  • Patients with amenorrhoea for more than 12 months
  • Never received treatment for menopausal symptoms
  • Never received menopausal hormone therapy
  • Reporting a minimum of 21 hot flushes per week at the time of entry into the study

Who cannot join

  • Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks
  • Patients who in the judgment of the investigator will be unable to comply with protocol requirements.
  • Patients with significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases;
  • Patients with uncontrolled hypertension,
  • Patients with undiagnosed vaginal bleeding

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital

    Hong Kong

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Multiple-Dose Escalation Study of the Effect of Danggui Buxue Tang on Symptomatic Postmenopausal Hong Kong Chinese Women (Continuation of a Completed Study Using the Same Formula)

Main purpose of the study is to look for an optimal dose for the treatment of menopausal symptoms with the Chinese Herbal Medicines containing Dang Gui and Huang Qi.

Read the detailed description

The menopause implies the permanent cessation of menstrual bleeding. In western medicine, this is associated either with the spontaneous failure of normal ovarian function, or it may also result from surgical removal of the ovaries or as a consequence of chemotherapy or radiotherapy. In western medicine, the usual treatment of the menopause is the use of oestrogen replacement therapy. However, treatment with oestrogen may result in unwanted side effects such as breast soreness and nausea. In addition, the long-term safety of oestrogen treatment has not been established. Oestrogen is therefore a valuable treatment for the menopause, but it is not without side effects. It remains to be seen whether Chinese Medicine as described in this proposal can prove to be an effective, safe and well tolerated treatment for the menopause. Dang Gui (Radix Angelicae Sinensis) is one Chinese herb that is recommended for the treatment of menopausal symptoms. Huang Qi is also used in the treatment of the menopausal symptoms to tonify Qi. We have now shown a beneficial effect of Danggui Buxue Tang on vasomotor symptoms in postmenopausal Chinese women (Re: CREC Ref. No. CRE-2002.152-T). However, we could not show a difference in the reduction in severity of symptoms between Danggui Buxue Tang and placebo. We now wish to confirm our initial findings, and we hope to obtain more reliable data by (1) only including women who have never used any type of treatment for their menopause and (2) by recruiting women who have more severe symptoms of the menopause.

Chinese Herbal Medicines containing Dang Gui and Huang Qi have been used for many years to treat menopausal women. There are few data on possible adverse effects of treatment with Chinese Herbal Medicine containing Dang Gui as well as Huang Qi..

The objective of present study is to investigate the dose response relationship to assess an optimal dose suitable for clinical use. The trial will be designed as a multiple-dose escalation clinical trial to obtain accurate information on the efficacy and safety when used for menopausal women. Since previous study has already confirmed that the dose used was efficacious, the main purpose of the study is to look for an optimal dose for the treatment of menopausal symptoms.

Conditions
Postmenopausal
Being tested
DBT-Danggui Buxue Tang
Keywords
Post-menopausal, Traditional Chinese Medicine, Randomized

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DBT-Danggui Buxue TangDrug

    Also called Danggui Buxue Tang

    Herbal Combination of Danggui (Radix Angelicae Sinensis) and Huangqi (Radix Astragali)in granules form, in 3 different dosage 6g/3g/1.5g, once time per day for 3 Months treatment

Study groups in NCT00420576
Study groupRoleWhat they receive
1ExperimentalLow Dose Danggui Buxue Tang (1.5g)
Receives: Drug: DBT-Danggui Buxue Tang
2ExperimentalMiddle Dose Danggui Buxue Tang(3g)
Receives: Drug: DBT-Danggui Buxue Tang
3ExperimentalHigh Dose Danggui Buxue Tang (6g)
Receives: Drug: DBT-Danggui Buxue Tang

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the changes in severity and frequency of hot flushes and sweats (menopausal symptoms)

    Measured: 5 Months

Secondary outcomes (2)

  1. the changes of score on the Menopause specific quality of life

    Measured: 5 Months

  2. the changes in values of various markers of risk for cardiovascular disease

    Measured: 5 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2007 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00420576
Sponsor's protocol ID
ICM/CTS/05/336
Status last verified
Jan 2007
First submitted
9 Jan 2007
Last updated
18 Dec 2008
Results posted
No
Data monitoring committee
No

Publications

  • Hagstad A, Janson PO. The epidemiology of climacteric symptoms. Acta Obstet Gynecol Scand Suppl. 1986;134:59-65. doi: 10.3109/00016348609157052.

    PubMed 3468732

  • Schneider HP, Gallagher JC. Moderation of the daily dose of HRT: benefits for patients. Maturitas. 1999 Nov;33 Suppl 1:S25-9. doi: 10.1016/s0378-5122(99)00060-2.

    PubMed 10661612

  • Au GK. Evaluation of the benefits and risks of hormone replacement therapy. Hong Kong Med J. 2000 Dec;6(4):381-9.

    PubMed 11177160

  • Blumel JE, Castelo-Branco C, Binfa L, Gramegna G, Tacla X, Aracena B, Cumsille MA, Sanjuan A. Quality of life after the menopause: a population study. Maturitas. 2000 Jan 15;34(1):17-23. doi: 10.1016/s0378-5122(99)00081-x.

    PubMed 10687878

  • Hall G, Pripp U, Schenck-Gustafsson K, Landgren BM. Long-term effects of hormone replacement therapy on symptoms of angina pectoris, quality of life and compliance in women with coronary artery disease. Maturitas. 1998 Jan 12;28(3):235-42. doi: 10.1016/s0378-5122(97)00080-7.

    PubMed 9571599

  • Zhu DP. Dong quai. Am J Chin Med. 1987;15(3-4):117-25. doi: 10.1142/S0192415X87000151.

    PubMed 3425569

  • Davis SR, Briganti EM, Chen RQ, Dalais FS, Bailey M, Burger HG. The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women. A randomised controlled trial. Med J Aust. 2001 Jan 15;174(2):68-71. doi: 10.5694/j.1326-5377.2001.tb143156.x.

    PubMed 11245505

  • Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-8. doi: 10.1016/S0140-6736(99)06457-0.

    PubMed 10675182

  • Chung TK, Yip SK, Lam P, Chang AM, Haines CJ. A randomized, double-blind, placebo-controlled, crossover study on the effect of oral oestradiol on acute menopausal symptoms. Maturitas. 1996 Oct;25(2):115-23. doi: 10.1016/0378-5122(96)01050-x.

    PubMed 8905602

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DBT-Danggui Buxue Tang in people with Postmenopausal, run by Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the changes in severity and frequency of hot flushes and sweats (menopausal symptoms) (time frame: 5 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00420576, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2008.

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